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Sunday, April 3, 2022

Cytokinetics: No Effect of Omecamtiv Mecarbil On Exercise Capacity in Heart Failure

 No Effect of Omecamtiv Mecarbil On Exercise Capacity

in Patients with Heart Failure with Reduced Ejection Fraction in METEORIC-HF

Healthcare Resource Utilization and Cost Analysis from GALACTIC-HF Demonstrate Treatment with Omecamtiv Mecarbil Led to 19% Cost Reduction Per Patient in Key Subgroup

Additional Results from GALACTIC-HF Indicate Treatment with Omecamtiv Mecarbil
Associated with Similar Risk Reduction in Both Hospitalized Patients and Outpatients


https://www.marketscreener.com/quote/stock/CYTOKINETICS-INCORPORATE-13479846/news/Cytokinetics-Announces-Results-From-METEORIC-HF-and-Additional-Data-From-GALACTIC-HF-Presented-at-th-39953238/

Bristol Myers: Sustained Improvements in Cardiomyopathy Trial

 Treatment with mavacamten showed sustained improvement in left ventricular outflow tract (LVOT) gradients, New York Heart Association (NYHA) Class and N-terminal pro brain natriuretic peptide (NT-proBNP) levels

At 48 and 84 Weeks, Mavacamten safety was consistent with that seen in the EXPLORER-HCM study

Interim results were presented as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Announces-Data-from-EXPLORER-LTE-Demonstrating-Sustained-Improvements-in-Clinic-39953239/

Hospitals saw negative operating margins in February for second consecutive month

 

  • Hospitals' operating margins were negative in February for the second consecutive month even as cases of the omicron variant waned, according to Kaufman Hall’s National Hospital Flash report. Negative margins in January were the first seen in 11 months.
  • The median Kaufman Hall Operating Margin Index was -3.45%, up from -4.25% in January but still well below levels hospitals can sustain, the report said.
  • Volumes for inpatient services fell while outpatient volumes staggered with revenues in those categories falling 19.3% and 5%, respectively, from January, according to the report.
Cases of the omicron variant peaked in January though swiftly plummeted in February as hospitals in turn saw fewer severely ill COVID-19 patients who stayed for shorter visits.

From January to February, patient days dropped 13.3% and average length of stay dropped 5.3% according to Kaufman Hall’s report, which draws on data from more than 900 hospitals across the country.

Major declines in COVID-19 care weren’t complemented by significant rises in outpatient care, as revenue in that category fell 5% month over month. Surgery volumes rose somewhat though, with operating room minutes up 6.5% month over month.

Ongoing, national labor shortages coupled with global supply chain issues drove up hospitals’ expenses up in recent months, though significantly lower volumes in February granted some relief.

Total expense per adjusted discharge fell 4.5% from January to February, while labor expense per adjusted discharge fell 6.1%. Non-labor expense per adjusted discharge fell 3.6%.

Despite those improvements, expenses are still high compared to this time last year.

Compared to February 2021, total expense per adjusted discharge was up 10.4%, labor expense per adjusted discharge was up 15.3%, and non-labor expense per adjusted discharge was up 8%.

"Margins, revenues, and inpatient volumes declined for most organizations in February, while outpatient care signaled only slow returns," Erik Swanson, senior vice president of Data and Analytics with Kaufman Hall, said.

"The metrics indicate a challenging recovery from the Omicron surge in the coming months," he said.

The median change in operating margin for hospitals fell 11.8% from January to February, according to the report. In February 2020, just before the pandemic started, the median change in operating margin was down 42.4%.

https://www.healthcaredive.com/news/hospital-margins-negative-february-kaufman-hall-COVID/621120/

US health spending growth decelerated in pandemic's second year

 

  • National health spending grew an estimated 4.2% in 2021, reaching almost $4.3 trillion, according to annual spending projections released by the CMS. That's a significant deceleration from the 9.7% growth rate seen in 2020, as the federal government ramped up spending to combat COVID-19, despite the increasing demand for patient care last year.
  • The CMS projects health spending will grow at an average rate of 4.9% between 2022 and 2024, and 5.3% between 2025 and 2030, to reach nearly $6.8 trillion by 2030.
  • Growth in the nation's GDP is projected to be 5.1% annually over the same period, meaning healthcare spending will make up 19.6% of the GDP by 2030. That's roughly the same as 2020's share.
The first year of the pandemic in 2020 saw a mammoth increase in health spending, according to previous accounting.

That year, utilization dropped off drastically, but supplemental federal spending for the provider relief fund and other public health investments drove the U.S.'s health spending growth to 9.7% in 2020, a mammoth jump from the previous years' rate of 4.3% — and the sharpest growth rate in more than a decade.

As a result of that increased health spending, along with a downturn in the overall economy, health spending as a percentage of the GDP rose from 17.6% in 2019 to nearly a fifth of the entire economy — 19.7% — in 2020.

Before the pandemic, the CMS predicted the U.S. wouldn't reach this one-fifth benchmark until 2028.

It's as of yet unclear whether the nation's spending increase will continue based on 2020's numbers, or whether the year was an outlier in terms of overall spending and growth rates.

Researchers including John Poisal, deputy director for National Health Statistics Group in the CMS, used the new projections, along with the CMS' actuarial and econometric modeling methods, to try to look forward at health spending over the next decade in a new report published in Health Affairs on Monday.

Health spending growth is expected to slow to 4.2%, closer to pre-pandemic levels, in 2021, mostly due to a decline in federal supplemental funding.

That deceleration is expected to continue in 2022 to 2024, compared to 2020, as utilization returns to more normal levels, federal funding dries up and health insurance enrollments begin to return to pre-COVID-19 distributions.

By the end of 2024, the economy should begin to more fully recover from COVID-19. The resulting economic growth will outpace health spending growth, leading health spending growth as a percentage of the GDP to decline to just over 18% in this period — still exceeding the pre-pandemic level of 17.6%, researchers projected.

By 2030, the health spending share of GDP is projected to reach 19.6%, influenced more heavily once again by traditional economic, demographic and health-specific factors that drive changes in health spending and enrollment.

"While there is still considerable uncertainty around the COVID-19 pandemic, its related health and economic impacts are projected to lessen in the next few years," Poisal said in a statement on the report. "From 2025 onward, we expect economic and demographic factors to reemerge as the most influential drivers of health sector spending trends."

In 2021 specifically, the CMS found spending related to the pandemic fell sharply. Researchers estimated it dropped down to roughly $287 billion, versus $418 billion in 2020.

That's also expected to have resulted in slower growth of spending on hospitals and physician and clinical services, though spending rates for both sectors are expected to accelerate in 2022 as demand for services rebounds.

Hospital spending is also projected to accelerate due to price growth, the CMS said.

Retail prescription drug spending accelerated in 2021 due to higher Medicaid drug spending as enrollment in the safety-net insurance hiked, but is forecast to slow in 2022.

Spending in Medicare and Medicaid is expected to have sharply accelerated in 2021, to 11.3% and 10.4% respectively as a result of faster projected growth in personal healthcare spending in Medicare, and faster enrollment growth in Medicaid.

Spending growth for both programs is expected to slow in 2022 and 2023 due to slowing service use and intensity of Medicare services, and as states are expected to resume eligibility checks for Medicaid, trimming rolls.

Private health insurance spending is estimated to have grown particularly rapidly after declining in 2020. That's due to greater use of medical goods and services, and stabilization of economic and employment disturbances, the CMS said. However, researchers said growing demand is expected to accelerate private health insurance spending growth this year.

The CMS expects 91.1% of the population was covered by health insurance in 2022 and that percentage will remain stable in 2022, mostly due to the gains in Medicaid enrollment.

But those gains are largely tied to the public health emergency, which incentivized states to pause eligibility checks for Medicaid coverage. After the end of the emergency, enrollment is projected to begin returning to pre-pandemic distributions, which will cause the insured rate to lag to 89.8% by 2030, the CMS said.

https://www.healthcaredive.com/news/cms-health-spending-covid-2021/621164/

Long-term health of patients, hospitals at stake as care delays continue

 The slowdown of the COVID-19 pandemic in the U.S. has done little to speed up Americans' return to healthcare.

Two years into the pandemic, healthcare experts are "very concerned" that patient volumes have yet to return to normal. That's because people continue to delay important screenings and care, raising concerns about the long-term implications for patient health and the effect on the nation's health system.  

The downturn in patient care has been widespread with volumes still trailing in settings and services ranging from inpatient to outpatient care, emergency room visits and even cardiac care, according to data from healthcare vendor Strata. It analyzed data from more than 170 health systems, representing more than 1,100 hospitals across the country including academic medical centers and children's and rural hospitals.  

For the past two years, even amid the outbreak of COVID-19, patient foot traffic still fell below pre-pandemic levels, underscoring just how many people stayed away from hospitals and other traditional healthcare settings.    

Some expected a sizable rebound in deferred care after visits plunged in 2020, but it never materialized to that extent. It's left some to wonder when the pendulum will swing back in the other direction. 

"The scary part that we haven't started talking about yet is what that means five years from now," said Sarah Alwardt, practice director for the Center for Healthcare Transformation within Avalere, a Washington D.C.-based consulting firm. 

Patient volumes are still 'in transition'

Even though COVID-19 sent hundreds of thousands in the U.S. to hospitals and stretched hospitals thin, inpatient volumes still fell markedly.

Inpatient admissions, including for COVID-19, dropped 9.7% in 2020 and 7% last year. Excluding patients with the virus, admissions slid 14.9% and 14% in 2020 and 2021, respectively, according to data from Strata. 

Even amid the pandemic, fewer patients have been admitted to the hospital

Healthcare vendor Strata analyzed data from more than 1,100 hospitals across the country.

It's not just hospital admissions. Fewer patients have turned up at emergency rooms, with declines of 21% and 15.5% in 2020 and 2021, respectively, according to Strata. 

Outpatient visits, not including testing and vaccinations, also trailed historical levels. They fell 16.5% in 2020 and 3.2% in 2021. 

Outpatient visits also declined during the past two years

Strata also analyzed the outpatient traffic of the more than 1,100 hospital systems it tracks, and even these more convenient visits for patients trail pre-pandemic levels.

 

"We're seeing delays in care, or deferral of care, that we're very, very concerned about," Steve Lefar, executive director of data science at Strata, said in an interview.  

Ever since the federal government declared a public health emergency in the spring of 2020, the virus, or the threat of it, has influenced patient behavior and created a drag on key patient volume metrics.    

How volumes have fared throughout the duration of the pandemic is a topic Chris Mast and his colleagues at Epic Research have kept a close eye on. They have analyzed electronic health record data from millions of patients to paint a clear picture of what has happened to healthcare utilization over the past two years. 

They found many Americans have missed key screenings for cervical, breast and colon cancers. Although there has been much talk about the need to return to "baseline" — or normal volume trends evident in 2019 — what Epic Research's analysis shows is that the nation has neither returned to baseline, nor has it made up for the screenings that were missed.

In order to catch up, the drop in missed screenings that fall below the historical trend would need to be mirrored above that baseline. 

Patients continue to delay key screenings including cervical cancer

Screenings for cervical cancer were down 10% in 2021 when comparing the average weekly screenings to the historical average.

Mast and his colleagues are unsure a catch-up in screenings will happen, especially as more time passes. Still, patients are sensitive to messaging and every year there is a predictable bump in screenings during breast cancer awareness month, he said.  

"What that tells me is that those messages have an impact," Mast noted. With this in mind, organizations should be prodding patients to return for these annual checkups, he added. 

Across the board, cancer screenings have fallen, worrying experts

With targeted messaging, experts are hoping to see a rebound in screenings.

It's not just cancer screenings. Emergency department visits have continued to lag throughout the pandemic. It's a trend that has puzzled healthcare experts. What happened to all those health emergencies? Was it possible people were having fewer heart attacks and strokes?

Emergency room visits still lag pre-pandemic volumes

A constant laggard in key patient volumes has been emergency room visits, prompting researchers to examine why.

"It was perplexing. As we drilled into it, we saw that in some cases they didn't really go anywhere," Mast said.

The data show that higher-acuity patients, like those experiencing heart attacks and strokes, were coming to the ER at levels above the baseline, while lower-acuity patients were coming in at rates lower than 2019 levels. 

"I would characterize the patterns of healthcare delivery, and people seeking healthcare, as being in transition. And we're still waiting to see where those things are going to settle out," Mast said. 

Threat to hospitals

The decline in patient demand was so acute that the federal government funneled billions of taxpayer dollars to hospitals around the country to prop them up financially as operations were seemingly turned upside overnight.  

As people deferred visits to the doctor and fewer were admitted to hospitals, it also meant insurers paid less for care than they were used to historically leading to record profits. 

But as federal relief funds dwindle and volumes sag, it also raises concerns about how providers will fare financially.

The deflated volumes are occurring as hospitals grapple with increased expenses, particularly those tied to salaries and benefits as many have struggled to find enough staffing resources. During numerous COVID-19 surges, facilities have had to pay surging rates for traveling nurses in order to backfill shortages.

These operating challenges will continue to squeeze margins for many hospital operators, healthcare analysts have said.

At the same time, the pandemic has accelerated the shift of care to outpatient settings.

Inpatient orthopedic procedures have decreased dramatically over the past two years compared with 2019, according to Strata's data. There has been a "massive shift" to outpatient facilities for these types of procedures, Lefar said, a service line that can be lucrative for many facilities. 

The continued migration of services from inpatient to outpatient will pose challenges for some operators, especially those without robust outpatient offerings. 

"The inpatient dependency is going to be a problem, there's just no two ways about it," Lefar said.

As healthcare executives consider how to move forward, experts such as Alwardt of Avalere say they need to think differently about how to interact with patients, especially after the meteoric rise in telehealth services. 

"They're so used to people coming to them," Alwardt said. 

Now, healthcare executives need to pivot their thinking to how can they proactively maintain those patient relationships, he added.

"This is going to take investment in a digital transformation that I don't know if they counted on having to do," he said. 

https://www.healthcaredive.com/news/2-years-after-covid-outbreak-patient-volume-woes-continue-for-health-syste/620251/

Saturday, April 2, 2022

Congress mulling new $55B restaurant COVID aid package

 Congress is mulling a new $55 billion aid package for restaurants and other industries battered by the coronavirus pandemic.

Restaurants are slated to receive $42 billion which is intended to backfill the 2021 Restaurant Relief Fund. That aid ran out before 2/3 of restaurants that applied could receive cash, according to Roll Call.

The House Rules Committee is scheduled to meet Tuesday to go over the bill and Democratic leaders in the chamber are currently seeing how much enthusiasm there is for the idea among members.

“We under-appropriated to begin with,” Rep Dean Phillips (D-Minnesota) told the outlet. “So this is about a make-good and not picking winners and losers. And that notion is picking up some steam, recognizing this is not a prospective COVID relief bill. This is a retrospective make-good.”

Restaurant
The 2021 Restaurant Relief Fund ran out of money before 2/3 of the restaurants that applied for aid could receive money.
Getty Images

The new spending would come during a midterm election year as the country races record inflation.

https://nypost.com/2022/04/02/congress-mulling-new-55b-restaurant-covid-aid-package/

Novartis wins FDA OK for radiopharmaceutical drug, cashing in on Endocyte deal

 

  • Novartis has won Food and Drug Administration approval to sell a radiopharmaceutical designed to treat a form of advanced prostate cancer in a key step forward for an area of research the Swiss drugmaker has prioritized in recent years.
  • The FDA cleared the infusion, known as Pluvicto, based on study results showing it could cut the risk of death and slow tumor growth in some of the sickest patients. Participants in the trial had already received other treatments and needed a new option to fight the spread of cancer cells.
  • U.S. regulators also approved Novartis’s diagnostic imaging agent, Locametz, which is designed to help doctors find patients eligible for treatment with Pluvicto, Novartis said in a statement. Locametz is used in a PET scan to identify men whose cancer expresses a certain biomarker.
Pluvicto is part of Novartis’s larger push into nuclear medicine and other cutting-edge technologies. The Swiss drugmaker picked up the therapy as part of its $2.1 billion purchase of Endocyte in 2018, following on the heels of its $3.9 billion acquisition of radiopharmaceutical specialist Advanced Accelerator Applications.

Radiopharmaceuticals are enticing because they offer a way to selectively target tumors and spare most of the healthy cells in the body from attack. But, as is typical of new cancer drugs, they can also be expensive. The wholesale acquisition cost of Pluvicto will be $42,500 a dose, Novartis said in an emailed statement.

Patients taking Pluvicto will receive a maximum of six doses, administered six weeks apart, and the actual cost for patients will depend on their insurance. Novartis said it’s optimistic that most payers will cover the therapy and emphasized that it had taken a “thoughtful approach” to pricing, weighing the drug’s innovative potential, the benefits for patients and the need to ensure access to treatment.

Novartis has already had success with another radiopharmaceutical developed by Advanced Accelerator Applications. The drug, Lutathera, is approved to treat certain digestive tract cancers and had sales of $115 million in the fourth quarter of 2021.

The FDA cleared Pluvicto for patients with metastatic castration-resistant prostate cancer who have already received chemotherapy and hormone-blocking treatments. Patients’ cancer cells must also express a protein called prostate-specific membrane antigen (PSMA), which can be found on the PET scan with Novartis’s new Locametz diagnostic kit.

Pluvicto combines a radioactive particle with a targeting compound known as a ligand. The ligand seeks out tumors expressing PSMA and then the radioisotope works to either kill cancer cells or damage them enough that they can’t replicate.

PSMA is generally not expressed at high levels on healthy cells, though there are some exceptions that may explain the higher rate of side effects for patients receiving Pluvicto. About 43% of patients on the therapy suffered from fatigue, 39% from dry mouth, 35% from nausea and 32% from anemia, Novartis said. Decreased appetite affected about one in five patients, as did constipation.

Novartis will individually produce Pluvicto in special facilities and ship it on demand for patients. The company said the therapy can be given by infusion in an outpatient setting.

Bayer and AstraZeneca, meanwhile, are also developing drugs that use radioisotopes. Bayer recently acquired two small biotechs to obtain a drug that, like Pluvicto, targets PSMA. 

https://www.biopharmadive.com/news/novartis-fda-approval-pluvicto-prostate-cancer-endocyte/620973/